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A Preclinical Study of the Safety and Efficacy of Occlusin™ 500 Artificial Embolization Device in Sheep

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Abstract

Introduction

This study evaluated the safety, effectiveness, and biodegradation of a new embolic agent, Occlusin™ 503 Artificial Embolization Device (OCL 503). The agent consists of biodegradable poly-lactic-co-glycolic acid microspheres (150–212 μm) coated with type I bovine collagen and was compared with Embosphere® Microspheres (300–500 μm) in this controlled study of uterine artery embolization (UAE) in sheep.

Methods

Unilateral UAE was performed in 32 adult ewes randomly assigned. Vessels were embolized to effective stasis. The cohort was divided into four groups, which were sacrificed at 1, 3, 6, and 12 months.

Results

Both agents were 100% effective in achieving stasis. At 6 months, all OCL 503-treated arteries were occluded, the microspheres degraded with time, and at 12 months all four animals examined demonstrated recanalization. OCL 503 was found in the untreated uterine artery in one animal with no other evidence of non target embolization. In the Embosphere-treated group, all vessels remained occluded and microspheres were detected in the contralateral uterine artery in 6 of 15 examined vessels and in 10 vaginal, 2 ovarian, and 1 vesical artery. No procedural-related complications were seen in either group.

Conclusions

OCL 503 is as effective an embolic agent as Embosphere® Microspheres when embolizing ovine uterine arteries and resorbs with time, allowing recanalization of the treated arteries. No device-related issues or adverse events were observed.

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Acknowledgments

The authors thank Tracey Clare (RN) for her assistance in performing this study. This work was supported by an operating grant from ViRexx Medical Corp., Edmonton, AB, Canada.

Conflict of interest

Robert Polakowski, Jennifer A Biliske, Paul B Tiege, and Irwin J Griffith are former employees of ViTexx Medical Corp., which provided an operating grant that supported the study. Irwin J Griffith is a current employee of IMBiotechnologies Ltd. There are no other conflicts.

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Authors and Affiliations

  1. Radiology and Diagnostic Imaging, Walter C. Mackenzie Health Sciences Centre, University of Alberta, 8440 - 112 Street, Edmonton, AB, T6G 2B7, Canada

    Richard J. Owen

  2. Laboratory Medicine and Pathology, Walter C. Mackenzie Health Sciences Centre, University of Alberta, 8440 - 112 Street, Edmonton, AB, T6G 2B7, Canada

    Patrick N. Nation

  3. BioLipids Inc, Suite #401, 11456 Jasper Ave, Edmonton, AB, T5K 0M1, Canada

    Robert Polakowski

  4. Biological Sciences, CW405, Biological Sciences Building, University of Alberta, 11455 Saskatchewan Drive, Edmonton, AB, T6G 2E9, Canada

    Jennifer A. Biliske

  5. Lipid Products Research Alberta (LiPRA), 410 Agriculture/Forestry Centre, University of Alberta, Edmonton, AB, T6G 2P5, Canada

    Paul B. Tiege

  6. IMBiotechnologies Ltd, Suite 113, Advanced Technology Centre, 9650 20th Ave, Edmonton, AB, T6N 1G1, Canada

    Irwin J. Griffith

Authors
  1. Richard J. Owen
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  2. Patrick N. Nation
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  3. Robert Polakowski
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  4. Jennifer A. Biliske
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  5. Paul B. Tiege
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  6. Irwin J. Griffith
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Corresponding author

Correspondence to Richard J. Owen.

Additional information

This work was conducted at the University of Alberta, Edmonton, Ab, Canada.

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Owen, R.J., Nation, P.N., Polakowski, R. et al. A Preclinical Study of the Safety and Efficacy of Occlusin™ 500 Artificial Embolization Device in Sheep. Cardiovasc Intervent Radiol 35, 636–644 (2012). https://doi.org/10.1007/s00270-011-0218-7

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  • DOI: https://doi.org/10.1007/s00270-011-0218-7

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